DEVICE: Nitrocef Matchbook™ (00819398028547)
Device Identifier (DI) Information
Nitrocef Matchbook™
Z108
In Commercial Distribution
Z108
HARDY DIAGNOSTICS
Z108
In Commercial Distribution
Z108
HARDY DIAGNOSTICS
Nitrocef Matchbook™, chromogenic nitrocefin test for beta lactamase, on paper strip, 10 tests per package
New Easy-to-Use MatchBook Format. Hardy Diagnostics now offers a more convenient way of testing ß-lactamase activity in bacteria. The new Nitrocef MatchBook™ is a rapid test that allows you to quickly pick your colonies and perform the test at the same time! Easier and faster than a disk!
The rapid Nitrocef test consists of a paper match-stick that is impregnated with the Nitrocefin reagent, which is a chromogenic cephalosporin. This rapid test can yield clinically relevant information earlier than an MIC test. A positive ß-lactamase test can predict resistance to such antibiotics as penicillin, ampicillin, amoxicillin, and other ß-lactamase containing drugs for the following organisms:
• Neisseria gonorrhoeae
• Haemophilus spp.
• Moraxella (Branhamella) catarrhalis
• Staphylococcus spp.
• Enterococcus spp.
• Anaerobes (such as some species of Bacteroides, Porphyromonas, Clostridium, Fusobacterium, Prevotella)
The rapid Nitrocef MatchBookTM can be used for all of the above organisms with results in 5 minutes or less, with the exception of some Staphylococcus spp. that may take up to one hour. The ß-lactamase test is preferred to disk diffusion and agar dilution for the detection of plasmid-mediated beta-lactamase resistance in gonococci. Now contains a larger reaction pad.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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43557 | Beta-lactamase production microbial reagent IVD |
A substance or reactant, sometimes referred to as nitrocefin reagent, intended to be used in microbial testing to detect the enzyme beta-lactamase, produced by a microorganism isolated from a clinical specimen by culture.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JTO | Discs, Strips And Reagents, Microorganism Differentiation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than -10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ef6ab53e-7324-4d2d-bad0-eaecbe9dcb74
July 03, 2020
1
June 25, 2020
July 03, 2020
1
June 25, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00819398027526
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-266-2222
techservice@hardydiagnostics.com
techservice@hardydiagnostics.com